Vvax001 Cancer Vaccine in (Pre) Malignant Cervical Lesions

Cervical Cancer Clinical Trial

Official title:

Immune Modulating Effects and Safety of Vvax001, a Therapeutic Semliki Forest Virus Based Cancer Vaccine, in Patients With a History of (Pre) Malignant Cervical Lesions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141463
• Other study ID #: Vvax001-UMCG-01
• Secondary ID: 2015-004979-74NL
• Status: Completed
• Phase: Phase 1
• Start date: January 13, 2017
• Est. completion date: November 28, 2017

Study information

• Verified date: November 2017
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Immune modulating effects and safety of Vvax001; different dosages will be tested in patients with a history of (pre) malignant cervical lesions.

Description:

Vvax001 is a therapeutic cancer vaccine consisting of a replication-incompetent Semliki Forest Virus (SFV) vector encoding HPV-derived tumor antigens. Patients will receive three consecutive doses, with an interval of 3 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 28, 2017
• Est. primary completion date: November 28, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A history of CIN II and III OR cervical cancer

• Minimally 12 weeks after completion of treatment

• Age of 18 years and older

• Baseline laboratory findings; adequate hepatic, renal ,and bone marrow function, HIV- and HBV-negative

• Patients of child-bearing potential should test negative using a serum pregnancy test and agree to utilize effective contraception during the entire treatment and follow-up period of the study

• Written informed consent according to local guidelines

Exclusion Criteria:

• Prior treatment with immunotherapeutic agents against HPV

• History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or current or prior use (4 weeks before start of the study) of high dose immunosuppressive therapy.

• History of a second malignancy except curatively treated low-stage tumors with a histology that can be differentiated from the cervical cancer type

• Participation in a study with another investigational drug within 30 days prior to the enrolment in this study

• Any condition that in the opinion of the investigator could interfere with the conduct of the study

Related Conditions & MeSH terms

• Cervical Cancer
• CIN 2/3
• Uterine Cervical Neoplasms

Intervention

Biological:
• Vvax001 therapeutic cancer vaccine
Vvax001 is a vaccine consisting of a replication-incompetent Semliki Forest Virus (SFV) vector encoding HPV-derived tumor antigens. Patients will receive three consecutive doses, with an interval of 3 weeks.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (3)

Lead Sponsor	Collaborator
University Medical Center Groningen	Dutch Cancer Society, ViciniVax B.V

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Daemen T, Riezebos-Brilman A, Regts J, Dontje B, van der Zee A, Wilschut J. Superior therapeutic efficacy of alphavirus-mediated immunization against human papilloma virus type 16 antigens in a murine tumour model: effects of the route of immunization. Antivir Ther. 2004 Oct;9(5):733-42. — View Citation

Draghiciu O, Boerma A, Hoogeboom BN, Nijman HW, Daemen T. A rationally designed combined treatment with an alphavirus-based cancer vaccine, sunitinib and low-dose tumor irradiation completely blocks tumor development. Oncoimmunology. 2015 May 27;4(10):e1029699. eCollection 2015 Oct. — View Citation

Riezebos-Brilman A, Walczak M, Regts J, Rots MG, Kamps G, Dontje B, Haisma HY, Wilschut J, Daemen T. A comparative study on the immunotherapeutic efficacy of recombinant Semliki Forest virus and adenovirus vector systems in a murine model for cervical cancer. Gene Ther. 2007 Dec;14(24):1695-704. Epub 2007 Oct 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity	To assess the immunological activity of Vvax001 by monitoring HPV-16 E6,7-specific T-cell immune responses	Day 28-31 and day 49-52 after first administration of Vvax001
Secondary	Number of treatment-related adverse events as assessed by CTCAE v4.0	To monitor the side effects/ adverse events related to intramuscular administration of Vvax001. Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.	up to 49-52 days after first administration of Vvax001